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CompletedNCT01959789Updated Oct 10, 2013

In-office Bleaching With a 2-day Interval Between Sessions: Tooth Sensitivity

An observational study in Dentin Sensitivity, sponsored by Universidade Estadual de Ponta Grossa. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-10.

Sponsored by Universidade Estadual de Ponta Grossa · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2 days after the first bleaching session without increasing the bleaching-induced tooth sensitivity

Read the detailed description

The in-office bleaching uses 35% hydrogen peroxide gel which is applied in 2 to 3 sessions usually with one week interval between sessions, without a scientific and plausible reason for this recommendation (. The aim of this study was to evaluate the tooth sensitivity (TS) risk using a shorter interval between clinical sessions. Methods: In this randomized, single-blind study, 40 young patients with color C2 or darker were selected and randomly divided in two groups. In the 7-day group, two bleaching sessions with a 35% hydrogen peroxide gel (Whiteness HP Blue Calcium - FGM) were performed with a one-week interval and in the 2-day group, the same protocol was performed but with a 2-day interval. TS was recorded on a 0-10 visual analog scale up to 48 h after bleaching. The color evaluation was performed at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The absolute risk of TS (%) was evaluated by Fisher´s exact. The TS intensity was evaluated by two-way repeated measured ANOVA and color changes (ΔSGU and ΔE) were evaluated by Student´s t-test (alpha = 5%).

02

Conditions studied

  • Dentin Sensitivity

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Keywords

  • Randomized Controlled Clinical Trial
  • Tooth Bleaching
03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

Browse Dentin Sensitivity studies →

Lead sponsor

Universidade Estadual de Ponta Grossa is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants included in this clinical trial were at least 18 years old and had good general and oral health. Participants were recruited by means of visual communication through posters in the university and in stores at Umuarama city. A total of 116 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

The participants should have:

At least six maxillary and mandibular anterior teeth caries-free. Without restorations on the labial surfaces. The central incisors should be C2 or darker according to a value-oriented shade guide (Vita Lumin).

Exclusion criteria

-

Exclusion Criteria:

Pre-existing anterior restorations. Pregnant/lactating. Severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).

Taking any drug with anti-inflammatory and antioxidant action. Bruxism habits or any other pathology that could cause Tooth Sensbility (such as recession, dentine exposure).

-

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Control

    Standard treatment

  • 2 days

    bleaching treatments made in 2 days

06

What researchers measure

Primary outcomes

  1. Tooth sensibility

    Time frame: 1 year

Secondary outcomes

  1. Color

    Time frame: 1 year

07

Study locations

1 site
  • Universidade Paranaense - UNIPAR
    Umuarama, Paraná 87.502-210, Brazil
08

References and documents

Publications

  • de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23. PubMed 25257824 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2011, a primary completion of Dec 2011 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2013
First posted
Oct 10, 2013
Start
Aug 2011
Primary completionActual
Dec 2011
CompletionActual
Aug 2012
Last update
Oct 10, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01959789
Lead sponsor
Universidade Estadual de Ponta Grossa
Responsible party
Eloisa Andrade de Paula (Student, Universidade Estadual de Ponta Grossa) — Principal investigator
First posted
Oct 10, 2013
Start date
Aug 2011
Primary completion
Dec 2011
Completion
Aug 2012
Last update
Oct 10, 2013

Study contacts

Eloisa A Paula, MD
principal investigator · Universidade Estadual de Ponta Grossa

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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